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Chloroquine for Treatment of Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00224978
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : November 18, 2009
Sponsor:
Information provided by:
National Institute of Neurology and Neurosurgery, Mexico

Brief Summary:
Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma Multiforme.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Chloroquine Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Chloroquine as Adjuvant to the Treatment of Glioblastoma Multiforme, A Randomized Trial
Study Start Date : January 2005
Study Completion Date : August 2005





Primary Outcome Measures :
  1. Survival after surgery

Secondary Outcome Measures :
  1. End-point evaluation, survival at two years


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Tumor restricted to one hemisphere of the brain
  • Karnofsky scale >7
  • Histologically confirmed GBM in first or second recurrence or relapse
  • Adequate hematologic, hepatic and renal function
  • Karnofsky performance status score ≥ 70%
  • Life expectancy ≥ 16 weeks

Exclusion Criteria:

  • Gastrointestinal dysfunction
  • Compromised cardiac function
  • Concurrent severe and /or uncontrolled medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224978


Locations
Mexico
National Institute of Neurology and Neurosurgery
Mexico City, Mexico, 14269
Sponsors and Collaborators
National Institute of Neurology and Neurosurgery, Mexico
Investigators
Principal Investigator: Julio Sotelo, MD National Institute of Neurology and Neurosurgery of Mexico

Publications of Results:
ClinicalTrials.gov Identifier: NCT00224978     History of Changes
Other Study ID Numbers: 14/99
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Chloroquine
Chloroquine diphosphate
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics